Trial Outcomes & Findings for A Study of MK-8189 in Participants With Bipolar I Disorder (MK-8189-020) (NCT NCT06273774)
NCT ID: NCT06273774
Last Updated: 2025-08-17
Results Overview
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
34 participants
Primary outcome timeframe
Up to 28 days
Results posted on
2025-08-17
Participant Flow
After the safety and tolerability was reviewed from the first cohort of Panel A, a protocol amendment was written to give the option to enroll either Panel B or Panel C. Panel C was selected to be enrolled; no participants were enrolled in Panel B and no data was collected for this panel.
Participant milestones
| Measure |
Panel A: 24 mg MK-8189
Participants received 24 mg MK-8189 once daily (QD) for 14 days.
|
Panel A: Placebo
Participants received Panel A MK-8189-matching placebo QD for 14 days.
|
Panel B: 16 & 24 mg MK-8189
Participants received 16 mg MK-8189 QD on Days 1 to 3 and 24 mg MK-8189 QD on Days 4 to 14. No participants were enrolled in Panel B.
|
Panel B: Placebo
Participants received Panel B MK-8189 matching placebo on days 1-14. No participants were enrolled in Panel B.
|
Panel C: 8, 16, & 24 mg MK-8189
Participants received 8 mg MK-8189 Day 1, 16 mg on Day 2, and 24 mg on QD Days 3 to 14.
|
Panel C Placebo
Participants received Panel C MK-8189-matching placebo QD for 14 days.
|
|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
12
|
5
|
0
|
0
|
13
|
4
|
|
Overall Study
COMPLETED
|
12
|
5
|
0
|
0
|
12
|
3
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
0
|
1
|
1
|
Reasons for withdrawal
| Measure |
Panel A: 24 mg MK-8189
Participants received 24 mg MK-8189 once daily (QD) for 14 days.
|
Panel A: Placebo
Participants received Panel A MK-8189-matching placebo QD for 14 days.
|
Panel B: 16 & 24 mg MK-8189
Participants received 16 mg MK-8189 QD on Days 1 to 3 and 24 mg MK-8189 QD on Days 4 to 14. No participants were enrolled in Panel B.
|
Panel B: Placebo
Participants received Panel B MK-8189 matching placebo on days 1-14. No participants were enrolled in Panel B.
|
Panel C: 8, 16, & 24 mg MK-8189
Participants received 8 mg MK-8189 Day 1, 16 mg on Day 2, and 24 mg on QD Days 3 to 14.
|
Panel C Placebo
Participants received Panel C MK-8189-matching placebo QD for 14 days.
|
|---|---|---|---|---|---|---|
|
Overall Study
Participant was out of state.
|
0
|
0
|
0
|
0
|
0
|
1
|
|
Overall Study
Lost to Follow-up
|
0
|
0
|
0
|
0
|
1
|
0
|
Baseline Characteristics
A Study of MK-8189 in Participants With Bipolar I Disorder (MK-8189-020)
Baseline characteristics by cohort
| Measure |
Panel A: 24 mg MK-8189
n=12 Participants
Participants received 24 mg MK-8189 once daily (QD) for 14 days.
|
Panel A: Placebo
n=5 Participants
Participants received Panel A MK-8189-matching placebo QD for 14 days.
|
Panel C: 8, 16, & 24 mg MK-8189
n=13 Participants
Participants received 8 mg MK-8189 Day 1, 16 mg on Day 2, and 24 mg on QD Days 3 to 14.
|
Panel C Placebo
n=4 Participants
Participants received Panel C MK-8189-matching placebo QD for 14 days.
|
Total
n=34 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
43.0 Years
STANDARD_DEVIATION 11.5 • n=5 Participants
|
40.8 Years
STANDARD_DEVIATION 11.9 • n=7 Participants
|
43.1 Years
STANDARD_DEVIATION 12.6 • n=5 Participants
|
51.5 Years
STANDARD_DEVIATION 10.0 • n=4 Participants
|
43.7 Years
STANDARD_DEVIATION 11.7 • n=21 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
16 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
8 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
18 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
5 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
10 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
28 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Black or African American
|
5 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
18 Participants
n=21 Participants
|
|
Race (NIH/OMB)
White
|
7 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
15 Participants
n=21 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
PRIMARY outcome
Timeframe: Up to 28 daysPopulation: All participants who received at least one dose of treatment were included in the analysis. No participants were enrolled in Panel B and no data was collected for Panel B. One participant in Panel C receiving 24 mg MK-8189 experienced an adverse event and was down-titrated to 12 mg MK-8189 per protocol.
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention.
Outcome measures
| Measure |
Panel A: MK-8189 24 mg
n=12 Participants
Participants received 24 mg of MK-8189 once daily (QD) for 14 days.
|
Panel A: Placebo
n=5 Participants
Participants received Panel A MK-8189-matching placebo QD for 14 days.
|
Panel B: 16 & 24 mg MK-8189
Participants received 16 mg MK-8189 QD on Days 1 to 3 and 24 mg MK-8189 QD on Days 4 to 14. No participants were enrolled in Panel B.
|
Panel B: Placebo
Participants received Panel B MK-8189 matching placebo on days 1-14. No participants were enrolled in Panel B.
|
Panel C: MK-8189 8 mg
n=13 Participants
Participants received 8 mg of MK-8189 on Day 1.
|
Panel C: 16 mg MK-8189
n=13 Participants
Participants received 16 mg of MK-8189 on Day 2.
|
Panel C: MK-8189 24 mg
n=13 Participants
Participants received 24 mg of MK-8189 on Days 3 to 14. One participant received 24 mg of MK-8189 on Days 3-8 and then was titrated down to 12 mg for Days 9-14 due to an AE.
|
Panel C: MK-8189 12 mg
n=1 Participants
Participant was down-titrated per protocol to 12 mg of MK-8189 for Days 9 through 14.
|
Panel C: Placebo
n=4 Participants
Participants received MK-8189-matching placebo QD for up to 14 days.
|
|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants Who Experience One or More Adverse Events (AEs)
|
9 Participants
|
4 Participants
|
—
|
—
|
1 Participants
|
4 Participants
|
6 Participants
|
0 Participants
|
1 Participants
|
PRIMARY outcome
Timeframe: Up to 14 daysPopulation: All participants who received at least one dose of treatment were included in the analysis. No participants were enrolled in Panel B and no data was collected for Panel B. One participant in Panel C receiving 24 mg MK-8189 experienced an adverse event and was down-titrated to 12 mg MK-8189 per protocol.
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention.
Outcome measures
| Measure |
Panel A: MK-8189 24 mg
n=12 Participants
Participants received 24 mg of MK-8189 once daily (QD) for 14 days.
|
Panel A: Placebo
n=5 Participants
Participants received Panel A MK-8189-matching placebo QD for 14 days.
|
Panel B: 16 & 24 mg MK-8189
Participants received 16 mg MK-8189 QD on Days 1 to 3 and 24 mg MK-8189 QD on Days 4 to 14. No participants were enrolled in Panel B.
|
Panel B: Placebo
Participants received Panel B MK-8189 matching placebo on days 1-14. No participants were enrolled in Panel B.
|
Panel C: MK-8189 8 mg
n=13 Participants
Participants received 8 mg of MK-8189 on Day 1.
|
Panel C: 16 mg MK-8189
n=13 Participants
Participants received 16 mg of MK-8189 on Day 2.
|
Panel C: MK-8189 24 mg
n=13 Participants
Participants received 24 mg of MK-8189 on Days 3 to 14. One participant received 24 mg of MK-8189 on Days 3-8 and then was titrated down to 12 mg for Days 9-14 due to an AE.
|
Panel C: MK-8189 12 mg
n=1 Participants
Participant was down-titrated per protocol to 12 mg of MK-8189 for Days 9 through 14.
|
Panel C: Placebo
n=4 Participants
Participants received MK-8189-matching placebo QD for up to 14 days.
|
|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants Who Discontinue Study Treatment Due to an AE
|
3 Participants
|
1 Participants
|
—
|
—
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
Adverse Events
Panel A: MK-8189 24 mg
Serious events: 2 serious events
Other events: 9 other events
Deaths: 0 deaths
Panel A: Placebo
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Panel C: MK-8189 8 mg
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Panel C: MK-8189 16 mg
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Panel C: MK-8189 24 mg
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Panel C: MK-8189 12 mg
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Panel C: Placebo
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Panel A: MK-8189 24 mg
n=12 participants at risk
Participants received 24 mg of MK-8189 once daily (QD) for 14 days.
|
Panel A: Placebo
n=5 participants at risk
Participants received Panel A MK-8189-matching placebo QD for 14 days.
|
Panel C: MK-8189 8 mg
n=13 participants at risk
Participants received 8 mg of MK-8189 on Day 1.
|
Panel C: MK-8189 16 mg
n=13 participants at risk
Participants received 16 mg of MK-8189 on Day 2.
|
Panel C: MK-8189 24 mg
n=13 participants at risk
Participants received 24 mg of MK-8189 on Days 3 to 14. One participant received 24 mg of MK-8189 on Days 3-8 and then was titrated down to 12 mg for Days 9-14 due to an AE.
|
Panel C: MK-8189 12 mg
n=1 participants at risk
Participant was down-titrated per protocol to 12 mg of MK-8189 for Days 9 through 14.
|
Panel C: Placebo
n=4 participants at risk
Participants received MK-8189-matching placebo QD for up to 14 days.
|
|---|---|---|---|---|---|---|---|
|
Psychiatric disorders
Bipolar I disorder
|
8.3%
1/12 • Number of events 1 • Up to 28 days.
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. No participants were enrolled in Panel B and no data was collected for Panel B. One participant in Panel C receiving 24 mg MK-8189 experienced an adverse event and was down-titrated to 12 mg MK-8189 per protocol. AEs were reported separately for this participant at the 12 mg dose.
|
0.00%
0/5 • Up to 28 days.
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. No participants were enrolled in Panel B and no data was collected for Panel B. One participant in Panel C receiving 24 mg MK-8189 experienced an adverse event and was down-titrated to 12 mg MK-8189 per protocol. AEs were reported separately for this participant at the 12 mg dose.
|
0.00%
0/13 • Up to 28 days.
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. No participants were enrolled in Panel B and no data was collected for Panel B. One participant in Panel C receiving 24 mg MK-8189 experienced an adverse event and was down-titrated to 12 mg MK-8189 per protocol. AEs were reported separately for this participant at the 12 mg dose.
|
0.00%
0/13 • Up to 28 days.
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. No participants were enrolled in Panel B and no data was collected for Panel B. One participant in Panel C receiving 24 mg MK-8189 experienced an adverse event and was down-titrated to 12 mg MK-8189 per protocol. AEs were reported separately for this participant at the 12 mg dose.
|
0.00%
0/13 • Up to 28 days.
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. No participants were enrolled in Panel B and no data was collected for Panel B. One participant in Panel C receiving 24 mg MK-8189 experienced an adverse event and was down-titrated to 12 mg MK-8189 per protocol. AEs were reported separately for this participant at the 12 mg dose.
|
0.00%
0/1 • Up to 28 days.
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. No participants were enrolled in Panel B and no data was collected for Panel B. One participant in Panel C receiving 24 mg MK-8189 experienced an adverse event and was down-titrated to 12 mg MK-8189 per protocol. AEs were reported separately for this participant at the 12 mg dose.
|
0.00%
0/4 • Up to 28 days.
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. No participants were enrolled in Panel B and no data was collected for Panel B. One participant in Panel C receiving 24 mg MK-8189 experienced an adverse event and was down-titrated to 12 mg MK-8189 per protocol. AEs were reported separately for this participant at the 12 mg dose.
|
|
Psychiatric disorders
Homicidal ideation
|
8.3%
1/12 • Number of events 1 • Up to 28 days.
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. No participants were enrolled in Panel B and no data was collected for Panel B. One participant in Panel C receiving 24 mg MK-8189 experienced an adverse event and was down-titrated to 12 mg MK-8189 per protocol. AEs were reported separately for this participant at the 12 mg dose.
|
0.00%
0/5 • Up to 28 days.
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. No participants were enrolled in Panel B and no data was collected for Panel B. One participant in Panel C receiving 24 mg MK-8189 experienced an adverse event and was down-titrated to 12 mg MK-8189 per protocol. AEs were reported separately for this participant at the 12 mg dose.
|
0.00%
0/13 • Up to 28 days.
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. No participants were enrolled in Panel B and no data was collected for Panel B. One participant in Panel C receiving 24 mg MK-8189 experienced an adverse event and was down-titrated to 12 mg MK-8189 per protocol. AEs were reported separately for this participant at the 12 mg dose.
|
0.00%
0/13 • Up to 28 days.
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. No participants were enrolled in Panel B and no data was collected for Panel B. One participant in Panel C receiving 24 mg MK-8189 experienced an adverse event and was down-titrated to 12 mg MK-8189 per protocol. AEs were reported separately for this participant at the 12 mg dose.
|
0.00%
0/13 • Up to 28 days.
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. No participants were enrolled in Panel B and no data was collected for Panel B. One participant in Panel C receiving 24 mg MK-8189 experienced an adverse event and was down-titrated to 12 mg MK-8189 per protocol. AEs were reported separately for this participant at the 12 mg dose.
|
0.00%
0/1 • Up to 28 days.
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. No participants were enrolled in Panel B and no data was collected for Panel B. One participant in Panel C receiving 24 mg MK-8189 experienced an adverse event and was down-titrated to 12 mg MK-8189 per protocol. AEs were reported separately for this participant at the 12 mg dose.
|
0.00%
0/4 • Up to 28 days.
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. No participants were enrolled in Panel B and no data was collected for Panel B. One participant in Panel C receiving 24 mg MK-8189 experienced an adverse event and was down-titrated to 12 mg MK-8189 per protocol. AEs were reported separately for this participant at the 12 mg dose.
|
Other adverse events
| Measure |
Panel A: MK-8189 24 mg
n=12 participants at risk
Participants received 24 mg of MK-8189 once daily (QD) for 14 days.
|
Panel A: Placebo
n=5 participants at risk
Participants received Panel A MK-8189-matching placebo QD for 14 days.
|
Panel C: MK-8189 8 mg
n=13 participants at risk
Participants received 8 mg of MK-8189 on Day 1.
|
Panel C: MK-8189 16 mg
n=13 participants at risk
Participants received 16 mg of MK-8189 on Day 2.
|
Panel C: MK-8189 24 mg
n=13 participants at risk
Participants received 24 mg of MK-8189 on Days 3 to 14. One participant received 24 mg of MK-8189 on Days 3-8 and then was titrated down to 12 mg for Days 9-14 due to an AE.
|
Panel C: MK-8189 12 mg
n=1 participants at risk
Participant was down-titrated per protocol to 12 mg of MK-8189 for Days 9 through 14.
|
Panel C: Placebo
n=4 participants at risk
Participants received MK-8189-matching placebo QD for up to 14 days.
|
|---|---|---|---|---|---|---|---|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/12 • Up to 28 days.
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. No participants were enrolled in Panel B and no data was collected for Panel B. One participant in Panel C receiving 24 mg MK-8189 experienced an adverse event and was down-titrated to 12 mg MK-8189 per protocol. AEs were reported separately for this participant at the 12 mg dose.
|
0.00%
0/5 • Up to 28 days.
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. No participants were enrolled in Panel B and no data was collected for Panel B. One participant in Panel C receiving 24 mg MK-8189 experienced an adverse event and was down-titrated to 12 mg MK-8189 per protocol. AEs were reported separately for this participant at the 12 mg dose.
|
0.00%
0/13 • Up to 28 days.
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. No participants were enrolled in Panel B and no data was collected for Panel B. One participant in Panel C receiving 24 mg MK-8189 experienced an adverse event and was down-titrated to 12 mg MK-8189 per protocol. AEs were reported separately for this participant at the 12 mg dose.
|
0.00%
0/13 • Up to 28 days.
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. No participants were enrolled in Panel B and no data was collected for Panel B. One participant in Panel C receiving 24 mg MK-8189 experienced an adverse event and was down-titrated to 12 mg MK-8189 per protocol. AEs were reported separately for this participant at the 12 mg dose.
|
7.7%
1/13 • Number of events 1 • Up to 28 days.
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. No participants were enrolled in Panel B and no data was collected for Panel B. One participant in Panel C receiving 24 mg MK-8189 experienced an adverse event and was down-titrated to 12 mg MK-8189 per protocol. AEs were reported separately for this participant at the 12 mg dose.
|
0.00%
0/1 • Up to 28 days.
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. No participants were enrolled in Panel B and no data was collected for Panel B. One participant in Panel C receiving 24 mg MK-8189 experienced an adverse event and was down-titrated to 12 mg MK-8189 per protocol. AEs were reported separately for this participant at the 12 mg dose.
|
0.00%
0/4 • Up to 28 days.
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. No participants were enrolled in Panel B and no data was collected for Panel B. One participant in Panel C receiving 24 mg MK-8189 experienced an adverse event and was down-titrated to 12 mg MK-8189 per protocol. AEs were reported separately for this participant at the 12 mg dose.
|
|
Gastrointestinal disorders
Diarrhoea
|
8.3%
1/12 • Number of events 1 • Up to 28 days.
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. No participants were enrolled in Panel B and no data was collected for Panel B. One participant in Panel C receiving 24 mg MK-8189 experienced an adverse event and was down-titrated to 12 mg MK-8189 per protocol. AEs were reported separately for this participant at the 12 mg dose.
|
20.0%
1/5 • Number of events 1 • Up to 28 days.
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. No participants were enrolled in Panel B and no data was collected for Panel B. One participant in Panel C receiving 24 mg MK-8189 experienced an adverse event and was down-titrated to 12 mg MK-8189 per protocol. AEs were reported separately for this participant at the 12 mg dose.
|
0.00%
0/13 • Up to 28 days.
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. No participants were enrolled in Panel B and no data was collected for Panel B. One participant in Panel C receiving 24 mg MK-8189 experienced an adverse event and was down-titrated to 12 mg MK-8189 per protocol. AEs were reported separately for this participant at the 12 mg dose.
|
7.7%
1/13 • Number of events 1 • Up to 28 days.
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. No participants were enrolled in Panel B and no data was collected for Panel B. One participant in Panel C receiving 24 mg MK-8189 experienced an adverse event and was down-titrated to 12 mg MK-8189 per protocol. AEs were reported separately for this participant at the 12 mg dose.
|
7.7%
1/13 • Number of events 1 • Up to 28 days.
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. No participants were enrolled in Panel B and no data was collected for Panel B. One participant in Panel C receiving 24 mg MK-8189 experienced an adverse event and was down-titrated to 12 mg MK-8189 per protocol. AEs were reported separately for this participant at the 12 mg dose.
|
0.00%
0/1 • Up to 28 days.
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. No participants were enrolled in Panel B and no data was collected for Panel B. One participant in Panel C receiving 24 mg MK-8189 experienced an adverse event and was down-titrated to 12 mg MK-8189 per protocol. AEs were reported separately for this participant at the 12 mg dose.
|
25.0%
1/4 • Number of events 2 • Up to 28 days.
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. No participants were enrolled in Panel B and no data was collected for Panel B. One participant in Panel C receiving 24 mg MK-8189 experienced an adverse event and was down-titrated to 12 mg MK-8189 per protocol. AEs were reported separately for this participant at the 12 mg dose.
|
|
Gastrointestinal disorders
Dry mouth
|
0.00%
0/12 • Up to 28 days.
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. No participants were enrolled in Panel B and no data was collected for Panel B. One participant in Panel C receiving 24 mg MK-8189 experienced an adverse event and was down-titrated to 12 mg MK-8189 per protocol. AEs were reported separately for this participant at the 12 mg dose.
|
0.00%
0/5 • Up to 28 days.
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. No participants were enrolled in Panel B and no data was collected for Panel B. One participant in Panel C receiving 24 mg MK-8189 experienced an adverse event and was down-titrated to 12 mg MK-8189 per protocol. AEs were reported separately for this participant at the 12 mg dose.
|
0.00%
0/13 • Up to 28 days.
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. No participants were enrolled in Panel B and no data was collected for Panel B. One participant in Panel C receiving 24 mg MK-8189 experienced an adverse event and was down-titrated to 12 mg MK-8189 per protocol. AEs were reported separately for this participant at the 12 mg dose.
|
0.00%
0/13 • Up to 28 days.
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. No participants were enrolled in Panel B and no data was collected for Panel B. One participant in Panel C receiving 24 mg MK-8189 experienced an adverse event and was down-titrated to 12 mg MK-8189 per protocol. AEs were reported separately for this participant at the 12 mg dose.
|
7.7%
1/13 • Number of events 1 • Up to 28 days.
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. No participants were enrolled in Panel B and no data was collected for Panel B. One participant in Panel C receiving 24 mg MK-8189 experienced an adverse event and was down-titrated to 12 mg MK-8189 per protocol. AEs were reported separately for this participant at the 12 mg dose.
|
0.00%
0/1 • Up to 28 days.
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. No participants were enrolled in Panel B and no data was collected for Panel B. One participant in Panel C receiving 24 mg MK-8189 experienced an adverse event and was down-titrated to 12 mg MK-8189 per protocol. AEs were reported separately for this participant at the 12 mg dose.
|
25.0%
1/4 • Number of events 1 • Up to 28 days.
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. No participants were enrolled in Panel B and no data was collected for Panel B. One participant in Panel C receiving 24 mg MK-8189 experienced an adverse event and was down-titrated to 12 mg MK-8189 per protocol. AEs were reported separately for this participant at the 12 mg dose.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.00%
0/12 • Up to 28 days.
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. No participants were enrolled in Panel B and no data was collected for Panel B. One participant in Panel C receiving 24 mg MK-8189 experienced an adverse event and was down-titrated to 12 mg MK-8189 per protocol. AEs were reported separately for this participant at the 12 mg dose.
|
0.00%
0/5 • Up to 28 days.
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. No participants were enrolled in Panel B and no data was collected for Panel B. One participant in Panel C receiving 24 mg MK-8189 experienced an adverse event and was down-titrated to 12 mg MK-8189 per protocol. AEs were reported separately for this participant at the 12 mg dose.
|
0.00%
0/13 • Up to 28 days.
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. No participants were enrolled in Panel B and no data was collected for Panel B. One participant in Panel C receiving 24 mg MK-8189 experienced an adverse event and was down-titrated to 12 mg MK-8189 per protocol. AEs were reported separately for this participant at the 12 mg dose.
|
0.00%
0/13 • Up to 28 days.
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. No participants were enrolled in Panel B and no data was collected for Panel B. One participant in Panel C receiving 24 mg MK-8189 experienced an adverse event and was down-titrated to 12 mg MK-8189 per protocol. AEs were reported separately for this participant at the 12 mg dose.
|
0.00%
0/13 • Up to 28 days.
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. No participants were enrolled in Panel B and no data was collected for Panel B. One participant in Panel C receiving 24 mg MK-8189 experienced an adverse event and was down-titrated to 12 mg MK-8189 per protocol. AEs were reported separately for this participant at the 12 mg dose.
|
0.00%
0/1 • Up to 28 days.
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. No participants were enrolled in Panel B and no data was collected for Panel B. One participant in Panel C receiving 24 mg MK-8189 experienced an adverse event and was down-titrated to 12 mg MK-8189 per protocol. AEs were reported separately for this participant at the 12 mg dose.
|
25.0%
1/4 • Number of events 1 • Up to 28 days.
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. No participants were enrolled in Panel B and no data was collected for Panel B. One participant in Panel C receiving 24 mg MK-8189 experienced an adverse event and was down-titrated to 12 mg MK-8189 per protocol. AEs were reported separately for this participant at the 12 mg dose.
|
|
Gastrointestinal disorders
Nausea
|
16.7%
2/12 • Number of events 3 • Up to 28 days.
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. No participants were enrolled in Panel B and no data was collected for Panel B. One participant in Panel C receiving 24 mg MK-8189 experienced an adverse event and was down-titrated to 12 mg MK-8189 per protocol. AEs were reported separately for this participant at the 12 mg dose.
|
0.00%
0/5 • Up to 28 days.
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. No participants were enrolled in Panel B and no data was collected for Panel B. One participant in Panel C receiving 24 mg MK-8189 experienced an adverse event and was down-titrated to 12 mg MK-8189 per protocol. AEs were reported separately for this participant at the 12 mg dose.
|
0.00%
0/13 • Up to 28 days.
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. No participants were enrolled in Panel B and no data was collected for Panel B. One participant in Panel C receiving 24 mg MK-8189 experienced an adverse event and was down-titrated to 12 mg MK-8189 per protocol. AEs were reported separately for this participant at the 12 mg dose.
|
0.00%
0/13 • Up to 28 days.
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. No participants were enrolled in Panel B and no data was collected for Panel B. One participant in Panel C receiving 24 mg MK-8189 experienced an adverse event and was down-titrated to 12 mg MK-8189 per protocol. AEs were reported separately for this participant at the 12 mg dose.
|
15.4%
2/13 • Number of events 2 • Up to 28 days.
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. No participants were enrolled in Panel B and no data was collected for Panel B. One participant in Panel C receiving 24 mg MK-8189 experienced an adverse event and was down-titrated to 12 mg MK-8189 per protocol. AEs were reported separately for this participant at the 12 mg dose.
|
0.00%
0/1 • Up to 28 days.
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. No participants were enrolled in Panel B and no data was collected for Panel B. One participant in Panel C receiving 24 mg MK-8189 experienced an adverse event and was down-titrated to 12 mg MK-8189 per protocol. AEs were reported separately for this participant at the 12 mg dose.
|
25.0%
1/4 • Number of events 1 • Up to 28 days.
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. No participants were enrolled in Panel B and no data was collected for Panel B. One participant in Panel C receiving 24 mg MK-8189 experienced an adverse event and was down-titrated to 12 mg MK-8189 per protocol. AEs were reported separately for this participant at the 12 mg dose.
|
|
Gastrointestinal disorders
Vomiting
|
16.7%
2/12 • Number of events 3 • Up to 28 days.
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. No participants were enrolled in Panel B and no data was collected for Panel B. One participant in Panel C receiving 24 mg MK-8189 experienced an adverse event and was down-titrated to 12 mg MK-8189 per protocol. AEs were reported separately for this participant at the 12 mg dose.
|
0.00%
0/5 • Up to 28 days.
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. No participants were enrolled in Panel B and no data was collected for Panel B. One participant in Panel C receiving 24 mg MK-8189 experienced an adverse event and was down-titrated to 12 mg MK-8189 per protocol. AEs were reported separately for this participant at the 12 mg dose.
|
0.00%
0/13 • Up to 28 days.
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. No participants were enrolled in Panel B and no data was collected for Panel B. One participant in Panel C receiving 24 mg MK-8189 experienced an adverse event and was down-titrated to 12 mg MK-8189 per protocol. AEs were reported separately for this participant at the 12 mg dose.
|
0.00%
0/13 • Up to 28 days.
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. No participants were enrolled in Panel B and no data was collected for Panel B. One participant in Panel C receiving 24 mg MK-8189 experienced an adverse event and was down-titrated to 12 mg MK-8189 per protocol. AEs were reported separately for this participant at the 12 mg dose.
|
0.00%
0/13 • Up to 28 days.
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. No participants were enrolled in Panel B and no data was collected for Panel B. One participant in Panel C receiving 24 mg MK-8189 experienced an adverse event and was down-titrated to 12 mg MK-8189 per protocol. AEs were reported separately for this participant at the 12 mg dose.
|
0.00%
0/1 • Up to 28 days.
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. No participants were enrolled in Panel B and no data was collected for Panel B. One participant in Panel C receiving 24 mg MK-8189 experienced an adverse event and was down-titrated to 12 mg MK-8189 per protocol. AEs were reported separately for this participant at the 12 mg dose.
|
25.0%
1/4 • Number of events 1 • Up to 28 days.
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. No participants were enrolled in Panel B and no data was collected for Panel B. One participant in Panel C receiving 24 mg MK-8189 experienced an adverse event and was down-titrated to 12 mg MK-8189 per protocol. AEs were reported separately for this participant at the 12 mg dose.
|
|
General disorders
Chest pain
|
0.00%
0/12 • Up to 28 days.
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. No participants were enrolled in Panel B and no data was collected for Panel B. One participant in Panel C receiving 24 mg MK-8189 experienced an adverse event and was down-titrated to 12 mg MK-8189 per protocol. AEs were reported separately for this participant at the 12 mg dose.
|
20.0%
1/5 • Number of events 1 • Up to 28 days.
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. No participants were enrolled in Panel B and no data was collected for Panel B. One participant in Panel C receiving 24 mg MK-8189 experienced an adverse event and was down-titrated to 12 mg MK-8189 per protocol. AEs were reported separately for this participant at the 12 mg dose.
|
0.00%
0/13 • Up to 28 days.
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. No participants were enrolled in Panel B and no data was collected for Panel B. One participant in Panel C receiving 24 mg MK-8189 experienced an adverse event and was down-titrated to 12 mg MK-8189 per protocol. AEs were reported separately for this participant at the 12 mg dose.
|
0.00%
0/13 • Up to 28 days.
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. No participants were enrolled in Panel B and no data was collected for Panel B. One participant in Panel C receiving 24 mg MK-8189 experienced an adverse event and was down-titrated to 12 mg MK-8189 per protocol. AEs were reported separately for this participant at the 12 mg dose.
|
0.00%
0/13 • Up to 28 days.
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. No participants were enrolled in Panel B and no data was collected for Panel B. One participant in Panel C receiving 24 mg MK-8189 experienced an adverse event and was down-titrated to 12 mg MK-8189 per protocol. AEs were reported separately for this participant at the 12 mg dose.
|
0.00%
0/1 • Up to 28 days.
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. No participants were enrolled in Panel B and no data was collected for Panel B. One participant in Panel C receiving 24 mg MK-8189 experienced an adverse event and was down-titrated to 12 mg MK-8189 per protocol. AEs were reported separately for this participant at the 12 mg dose.
|
0.00%
0/4 • Up to 28 days.
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. No participants were enrolled in Panel B and no data was collected for Panel B. One participant in Panel C receiving 24 mg MK-8189 experienced an adverse event and was down-titrated to 12 mg MK-8189 per protocol. AEs were reported separately for this participant at the 12 mg dose.
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/12 • Up to 28 days.
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. No participants were enrolled in Panel B and no data was collected for Panel B. One participant in Panel C receiving 24 mg MK-8189 experienced an adverse event and was down-titrated to 12 mg MK-8189 per protocol. AEs were reported separately for this participant at the 12 mg dose.
|
20.0%
1/5 • Number of events 1 • Up to 28 days.
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. No participants were enrolled in Panel B and no data was collected for Panel B. One participant in Panel C receiving 24 mg MK-8189 experienced an adverse event and was down-titrated to 12 mg MK-8189 per protocol. AEs were reported separately for this participant at the 12 mg dose.
|
0.00%
0/13 • Up to 28 days.
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. No participants were enrolled in Panel B and no data was collected for Panel B. One participant in Panel C receiving 24 mg MK-8189 experienced an adverse event and was down-titrated to 12 mg MK-8189 per protocol. AEs were reported separately for this participant at the 12 mg dose.
|
0.00%
0/13 • Up to 28 days.
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. No participants were enrolled in Panel B and no data was collected for Panel B. One participant in Panel C receiving 24 mg MK-8189 experienced an adverse event and was down-titrated to 12 mg MK-8189 per protocol. AEs were reported separately for this participant at the 12 mg dose.
|
0.00%
0/13 • Up to 28 days.
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. No participants were enrolled in Panel B and no data was collected for Panel B. One participant in Panel C receiving 24 mg MK-8189 experienced an adverse event and was down-titrated to 12 mg MK-8189 per protocol. AEs were reported separately for this participant at the 12 mg dose.
|
0.00%
0/1 • Up to 28 days.
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. No participants were enrolled in Panel B and no data was collected for Panel B. One participant in Panel C receiving 24 mg MK-8189 experienced an adverse event and was down-titrated to 12 mg MK-8189 per protocol. AEs were reported separately for this participant at the 12 mg dose.
|
0.00%
0/4 • Up to 28 days.
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. No participants were enrolled in Panel B and no data was collected for Panel B. One participant in Panel C receiving 24 mg MK-8189 experienced an adverse event and was down-titrated to 12 mg MK-8189 per protocol. AEs were reported separately for this participant at the 12 mg dose.
|
|
Injury, poisoning and procedural complications
Joint injury
|
0.00%
0/12 • Up to 28 days.
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. No participants were enrolled in Panel B and no data was collected for Panel B. One participant in Panel C receiving 24 mg MK-8189 experienced an adverse event and was down-titrated to 12 mg MK-8189 per protocol. AEs were reported separately for this participant at the 12 mg dose.
|
20.0%
1/5 • Number of events 1 • Up to 28 days.
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. No participants were enrolled in Panel B and no data was collected for Panel B. One participant in Panel C receiving 24 mg MK-8189 experienced an adverse event and was down-titrated to 12 mg MK-8189 per protocol. AEs were reported separately for this participant at the 12 mg dose.
|
0.00%
0/13 • Up to 28 days.
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. No participants were enrolled in Panel B and no data was collected for Panel B. One participant in Panel C receiving 24 mg MK-8189 experienced an adverse event and was down-titrated to 12 mg MK-8189 per protocol. AEs were reported separately for this participant at the 12 mg dose.
|
0.00%
0/13 • Up to 28 days.
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. No participants were enrolled in Panel B and no data was collected for Panel B. One participant in Panel C receiving 24 mg MK-8189 experienced an adverse event and was down-titrated to 12 mg MK-8189 per protocol. AEs were reported separately for this participant at the 12 mg dose.
|
0.00%
0/13 • Up to 28 days.
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. No participants were enrolled in Panel B and no data was collected for Panel B. One participant in Panel C receiving 24 mg MK-8189 experienced an adverse event and was down-titrated to 12 mg MK-8189 per protocol. AEs were reported separately for this participant at the 12 mg dose.
|
0.00%
0/1 • Up to 28 days.
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. No participants were enrolled in Panel B and no data was collected for Panel B. One participant in Panel C receiving 24 mg MK-8189 experienced an adverse event and was down-titrated to 12 mg MK-8189 per protocol. AEs were reported separately for this participant at the 12 mg dose.
|
0.00%
0/4 • Up to 28 days.
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. No participants were enrolled in Panel B and no data was collected for Panel B. One participant in Panel C receiving 24 mg MK-8189 experienced an adverse event and was down-titrated to 12 mg MK-8189 per protocol. AEs were reported separately for this participant at the 12 mg dose.
|
|
Injury, poisoning and procedural complications
Road traffic accident
|
0.00%
0/12 • Up to 28 days.
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. No participants were enrolled in Panel B and no data was collected for Panel B. One participant in Panel C receiving 24 mg MK-8189 experienced an adverse event and was down-titrated to 12 mg MK-8189 per protocol. AEs were reported separately for this participant at the 12 mg dose.
|
20.0%
1/5 • Number of events 1 • Up to 28 days.
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. No participants were enrolled in Panel B and no data was collected for Panel B. One participant in Panel C receiving 24 mg MK-8189 experienced an adverse event and was down-titrated to 12 mg MK-8189 per protocol. AEs were reported separately for this participant at the 12 mg dose.
|
0.00%
0/13 • Up to 28 days.
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. No participants were enrolled in Panel B and no data was collected for Panel B. One participant in Panel C receiving 24 mg MK-8189 experienced an adverse event and was down-titrated to 12 mg MK-8189 per protocol. AEs were reported separately for this participant at the 12 mg dose.
|
0.00%
0/13 • Up to 28 days.
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. No participants were enrolled in Panel B and no data was collected for Panel B. One participant in Panel C receiving 24 mg MK-8189 experienced an adverse event and was down-titrated to 12 mg MK-8189 per protocol. AEs were reported separately for this participant at the 12 mg dose.
|
0.00%
0/13 • Up to 28 days.
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. No participants were enrolled in Panel B and no data was collected for Panel B. One participant in Panel C receiving 24 mg MK-8189 experienced an adverse event and was down-titrated to 12 mg MK-8189 per protocol. AEs were reported separately for this participant at the 12 mg dose.
|
0.00%
0/1 • Up to 28 days.
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. No participants were enrolled in Panel B and no data was collected for Panel B. One participant in Panel C receiving 24 mg MK-8189 experienced an adverse event and was down-titrated to 12 mg MK-8189 per protocol. AEs were reported separately for this participant at the 12 mg dose.
|
0.00%
0/4 • Up to 28 days.
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. No participants were enrolled in Panel B and no data was collected for Panel B. One participant in Panel C receiving 24 mg MK-8189 experienced an adverse event and was down-titrated to 12 mg MK-8189 per protocol. AEs were reported separately for this participant at the 12 mg dose.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
8.3%
1/12 • Number of events 1 • Up to 28 days.
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. No participants were enrolled in Panel B and no data was collected for Panel B. One participant in Panel C receiving 24 mg MK-8189 experienced an adverse event and was down-titrated to 12 mg MK-8189 per protocol. AEs were reported separately for this participant at the 12 mg dose.
|
0.00%
0/5 • Up to 28 days.
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. No participants were enrolled in Panel B and no data was collected for Panel B. One participant in Panel C receiving 24 mg MK-8189 experienced an adverse event and was down-titrated to 12 mg MK-8189 per protocol. AEs were reported separately for this participant at the 12 mg dose.
|
0.00%
0/13 • Up to 28 days.
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. No participants were enrolled in Panel B and no data was collected for Panel B. One participant in Panel C receiving 24 mg MK-8189 experienced an adverse event and was down-titrated to 12 mg MK-8189 per protocol. AEs were reported separately for this participant at the 12 mg dose.
|
0.00%
0/13 • Up to 28 days.
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. No participants were enrolled in Panel B and no data was collected for Panel B. One participant in Panel C receiving 24 mg MK-8189 experienced an adverse event and was down-titrated to 12 mg MK-8189 per protocol. AEs were reported separately for this participant at the 12 mg dose.
|
0.00%
0/13 • Up to 28 days.
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. No participants were enrolled in Panel B and no data was collected for Panel B. One participant in Panel C receiving 24 mg MK-8189 experienced an adverse event and was down-titrated to 12 mg MK-8189 per protocol. AEs were reported separately for this participant at the 12 mg dose.
|
0.00%
0/1 • Up to 28 days.
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. No participants were enrolled in Panel B and no data was collected for Panel B. One participant in Panel C receiving 24 mg MK-8189 experienced an adverse event and was down-titrated to 12 mg MK-8189 per protocol. AEs were reported separately for this participant at the 12 mg dose.
|
0.00%
0/4 • Up to 28 days.
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. No participants were enrolled in Panel B and no data was collected for Panel B. One participant in Panel C receiving 24 mg MK-8189 experienced an adverse event and was down-titrated to 12 mg MK-8189 per protocol. AEs were reported separately for this participant at the 12 mg dose.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
8.3%
1/12 • Number of events 1 • Up to 28 days.
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. No participants were enrolled in Panel B and no data was collected for Panel B. One participant in Panel C receiving 24 mg MK-8189 experienced an adverse event and was down-titrated to 12 mg MK-8189 per protocol. AEs were reported separately for this participant at the 12 mg dose.
|
0.00%
0/5 • Up to 28 days.
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. No participants were enrolled in Panel B and no data was collected for Panel B. One participant in Panel C receiving 24 mg MK-8189 experienced an adverse event and was down-titrated to 12 mg MK-8189 per protocol. AEs were reported separately for this participant at the 12 mg dose.
|
0.00%
0/13 • Up to 28 days.
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. No participants were enrolled in Panel B and no data was collected for Panel B. One participant in Panel C receiving 24 mg MK-8189 experienced an adverse event and was down-titrated to 12 mg MK-8189 per protocol. AEs were reported separately for this participant at the 12 mg dose.
|
0.00%
0/13 • Up to 28 days.
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. No participants were enrolled in Panel B and no data was collected for Panel B. One participant in Panel C receiving 24 mg MK-8189 experienced an adverse event and was down-titrated to 12 mg MK-8189 per protocol. AEs were reported separately for this participant at the 12 mg dose.
|
0.00%
0/13 • Up to 28 days.
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. No participants were enrolled in Panel B and no data was collected for Panel B. One participant in Panel C receiving 24 mg MK-8189 experienced an adverse event and was down-titrated to 12 mg MK-8189 per protocol. AEs were reported separately for this participant at the 12 mg dose.
|
0.00%
0/1 • Up to 28 days.
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. No participants were enrolled in Panel B and no data was collected for Panel B. One participant in Panel C receiving 24 mg MK-8189 experienced an adverse event and was down-titrated to 12 mg MK-8189 per protocol. AEs were reported separately for this participant at the 12 mg dose.
|
0.00%
0/4 • Up to 28 days.
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. No participants were enrolled in Panel B and no data was collected for Panel B. One participant in Panel C receiving 24 mg MK-8189 experienced an adverse event and was down-titrated to 12 mg MK-8189 per protocol. AEs were reported separately for this participant at the 12 mg dose.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/12 • Up to 28 days.
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. No participants were enrolled in Panel B and no data was collected for Panel B. One participant in Panel C receiving 24 mg MK-8189 experienced an adverse event and was down-titrated to 12 mg MK-8189 per protocol. AEs were reported separately for this participant at the 12 mg dose.
|
0.00%
0/5 • Up to 28 days.
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. No participants were enrolled in Panel B and no data was collected for Panel B. One participant in Panel C receiving 24 mg MK-8189 experienced an adverse event and was down-titrated to 12 mg MK-8189 per protocol. AEs were reported separately for this participant at the 12 mg dose.
|
0.00%
0/13 • Up to 28 days.
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. No participants were enrolled in Panel B and no data was collected for Panel B. One participant in Panel C receiving 24 mg MK-8189 experienced an adverse event and was down-titrated to 12 mg MK-8189 per protocol. AEs were reported separately for this participant at the 12 mg dose.
|
0.00%
0/13 • Up to 28 days.
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. No participants were enrolled in Panel B and no data was collected for Panel B. One participant in Panel C receiving 24 mg MK-8189 experienced an adverse event and was down-titrated to 12 mg MK-8189 per protocol. AEs were reported separately for this participant at the 12 mg dose.
|
15.4%
2/13 • Number of events 2 • Up to 28 days.
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. No participants were enrolled in Panel B and no data was collected for Panel B. One participant in Panel C receiving 24 mg MK-8189 experienced an adverse event and was down-titrated to 12 mg MK-8189 per protocol. AEs were reported separately for this participant at the 12 mg dose.
|
0.00%
0/1 • Up to 28 days.
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. No participants were enrolled in Panel B and no data was collected for Panel B. One participant in Panel C receiving 24 mg MK-8189 experienced an adverse event and was down-titrated to 12 mg MK-8189 per protocol. AEs were reported separately for this participant at the 12 mg dose.
|
0.00%
0/4 • Up to 28 days.
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. No participants were enrolled in Panel B and no data was collected for Panel B. One participant in Panel C receiving 24 mg MK-8189 experienced an adverse event and was down-titrated to 12 mg MK-8189 per protocol. AEs were reported separately for this participant at the 12 mg dose.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/12 • Up to 28 days.
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. No participants were enrolled in Panel B and no data was collected for Panel B. One participant in Panel C receiving 24 mg MK-8189 experienced an adverse event and was down-titrated to 12 mg MK-8189 per protocol. AEs were reported separately for this participant at the 12 mg dose.
|
0.00%
0/5 • Up to 28 days.
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. No participants were enrolled in Panel B and no data was collected for Panel B. One participant in Panel C receiving 24 mg MK-8189 experienced an adverse event and was down-titrated to 12 mg MK-8189 per protocol. AEs were reported separately for this participant at the 12 mg dose.
|
0.00%
0/13 • Up to 28 days.
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. No participants were enrolled in Panel B and no data was collected for Panel B. One participant in Panel C receiving 24 mg MK-8189 experienced an adverse event and was down-titrated to 12 mg MK-8189 per protocol. AEs were reported separately for this participant at the 12 mg dose.
|
0.00%
0/13 • Up to 28 days.
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. No participants were enrolled in Panel B and no data was collected for Panel B. One participant in Panel C receiving 24 mg MK-8189 experienced an adverse event and was down-titrated to 12 mg MK-8189 per protocol. AEs were reported separately for this participant at the 12 mg dose.
|
7.7%
1/13 • Number of events 1 • Up to 28 days.
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. No participants were enrolled in Panel B and no data was collected for Panel B. One participant in Panel C receiving 24 mg MK-8189 experienced an adverse event and was down-titrated to 12 mg MK-8189 per protocol. AEs were reported separately for this participant at the 12 mg dose.
|
0.00%
0/1 • Up to 28 days.
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. No participants were enrolled in Panel B and no data was collected for Panel B. One participant in Panel C receiving 24 mg MK-8189 experienced an adverse event and was down-titrated to 12 mg MK-8189 per protocol. AEs were reported separately for this participant at the 12 mg dose.
|
0.00%
0/4 • Up to 28 days.
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. No participants were enrolled in Panel B and no data was collected for Panel B. One participant in Panel C receiving 24 mg MK-8189 experienced an adverse event and was down-titrated to 12 mg MK-8189 per protocol. AEs were reported separately for this participant at the 12 mg dose.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/12 • Up to 28 days.
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. No participants were enrolled in Panel B and no data was collected for Panel B. One participant in Panel C receiving 24 mg MK-8189 experienced an adverse event and was down-titrated to 12 mg MK-8189 per protocol. AEs were reported separately for this participant at the 12 mg dose.
|
0.00%
0/5 • Up to 28 days.
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. No participants were enrolled in Panel B and no data was collected for Panel B. One participant in Panel C receiving 24 mg MK-8189 experienced an adverse event and was down-titrated to 12 mg MK-8189 per protocol. AEs were reported separately for this participant at the 12 mg dose.
|
0.00%
0/13 • Up to 28 days.
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. No participants were enrolled in Panel B and no data was collected for Panel B. One participant in Panel C receiving 24 mg MK-8189 experienced an adverse event and was down-titrated to 12 mg MK-8189 per protocol. AEs were reported separately for this participant at the 12 mg dose.
|
0.00%
0/13 • Up to 28 days.
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. No participants were enrolled in Panel B and no data was collected for Panel B. One participant in Panel C receiving 24 mg MK-8189 experienced an adverse event and was down-titrated to 12 mg MK-8189 per protocol. AEs were reported separately for this participant at the 12 mg dose.
|
7.7%
1/13 • Number of events 1 • Up to 28 days.
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. No participants were enrolled in Panel B and no data was collected for Panel B. One participant in Panel C receiving 24 mg MK-8189 experienced an adverse event and was down-titrated to 12 mg MK-8189 per protocol. AEs were reported separately for this participant at the 12 mg dose.
|
0.00%
0/1 • Up to 28 days.
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. No participants were enrolled in Panel B and no data was collected for Panel B. One participant in Panel C receiving 24 mg MK-8189 experienced an adverse event and was down-titrated to 12 mg MK-8189 per protocol. AEs were reported separately for this participant at the 12 mg dose.
|
0.00%
0/4 • Up to 28 days.
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. No participants were enrolled in Panel B and no data was collected for Panel B. One participant in Panel C receiving 24 mg MK-8189 experienced an adverse event and was down-titrated to 12 mg MK-8189 per protocol. AEs were reported separately for this participant at the 12 mg dose.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.00%
0/12 • Up to 28 days.
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. No participants were enrolled in Panel B and no data was collected for Panel B. One participant in Panel C receiving 24 mg MK-8189 experienced an adverse event and was down-titrated to 12 mg MK-8189 per protocol. AEs were reported separately for this participant at the 12 mg dose.
|
0.00%
0/5 • Up to 28 days.
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. No participants were enrolled in Panel B and no data was collected for Panel B. One participant in Panel C receiving 24 mg MK-8189 experienced an adverse event and was down-titrated to 12 mg MK-8189 per protocol. AEs were reported separately for this participant at the 12 mg dose.
|
0.00%
0/13 • Up to 28 days.
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. No participants were enrolled in Panel B and no data was collected for Panel B. One participant in Panel C receiving 24 mg MK-8189 experienced an adverse event and was down-titrated to 12 mg MK-8189 per protocol. AEs were reported separately for this participant at the 12 mg dose.
|
7.7%
1/13 • Number of events 1 • Up to 28 days.
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. No participants were enrolled in Panel B and no data was collected for Panel B. One participant in Panel C receiving 24 mg MK-8189 experienced an adverse event and was down-titrated to 12 mg MK-8189 per protocol. AEs were reported separately for this participant at the 12 mg dose.
|
0.00%
0/13 • Up to 28 days.
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. No participants were enrolled in Panel B and no data was collected for Panel B. One participant in Panel C receiving 24 mg MK-8189 experienced an adverse event and was down-titrated to 12 mg MK-8189 per protocol. AEs were reported separately for this participant at the 12 mg dose.
|
0.00%
0/1 • Up to 28 days.
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. No participants were enrolled in Panel B and no data was collected for Panel B. One participant in Panel C receiving 24 mg MK-8189 experienced an adverse event and was down-titrated to 12 mg MK-8189 per protocol. AEs were reported separately for this participant at the 12 mg dose.
|
0.00%
0/4 • Up to 28 days.
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. No participants were enrolled in Panel B and no data was collected for Panel B. One participant in Panel C receiving 24 mg MK-8189 experienced an adverse event and was down-titrated to 12 mg MK-8189 per protocol. AEs were reported separately for this participant at the 12 mg dose.
|
|
Musculoskeletal and connective tissue disorders
Torticollis
|
8.3%
1/12 • Number of events 1 • Up to 28 days.
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. No participants were enrolled in Panel B and no data was collected for Panel B. One participant in Panel C receiving 24 mg MK-8189 experienced an adverse event and was down-titrated to 12 mg MK-8189 per protocol. AEs were reported separately for this participant at the 12 mg dose.
|
0.00%
0/5 • Up to 28 days.
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. No participants were enrolled in Panel B and no data was collected for Panel B. One participant in Panel C receiving 24 mg MK-8189 experienced an adverse event and was down-titrated to 12 mg MK-8189 per protocol. AEs were reported separately for this participant at the 12 mg dose.
|
0.00%
0/13 • Up to 28 days.
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. No participants were enrolled in Panel B and no data was collected for Panel B. One participant in Panel C receiving 24 mg MK-8189 experienced an adverse event and was down-titrated to 12 mg MK-8189 per protocol. AEs were reported separately for this participant at the 12 mg dose.
|
0.00%
0/13 • Up to 28 days.
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. No participants were enrolled in Panel B and no data was collected for Panel B. One participant in Panel C receiving 24 mg MK-8189 experienced an adverse event and was down-titrated to 12 mg MK-8189 per protocol. AEs were reported separately for this participant at the 12 mg dose.
|
0.00%
0/13 • Up to 28 days.
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. No participants were enrolled in Panel B and no data was collected for Panel B. One participant in Panel C receiving 24 mg MK-8189 experienced an adverse event and was down-titrated to 12 mg MK-8189 per protocol. AEs were reported separately for this participant at the 12 mg dose.
|
0.00%
0/1 • Up to 28 days.
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. No participants were enrolled in Panel B and no data was collected for Panel B. One participant in Panel C receiving 24 mg MK-8189 experienced an adverse event and was down-titrated to 12 mg MK-8189 per protocol. AEs were reported separately for this participant at the 12 mg dose.
|
0.00%
0/4 • Up to 28 days.
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. No participants were enrolled in Panel B and no data was collected for Panel B. One participant in Panel C receiving 24 mg MK-8189 experienced an adverse event and was down-titrated to 12 mg MK-8189 per protocol. AEs were reported separately for this participant at the 12 mg dose.
|
|
Nervous system disorders
Akathisia
|
0.00%
0/12 • Up to 28 days.
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. No participants were enrolled in Panel B and no data was collected for Panel B. One participant in Panel C receiving 24 mg MK-8189 experienced an adverse event and was down-titrated to 12 mg MK-8189 per protocol. AEs were reported separately for this participant at the 12 mg dose.
|
0.00%
0/5 • Up to 28 days.
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. No participants were enrolled in Panel B and no data was collected for Panel B. One participant in Panel C receiving 24 mg MK-8189 experienced an adverse event and was down-titrated to 12 mg MK-8189 per protocol. AEs were reported separately for this participant at the 12 mg dose.
|
0.00%
0/13 • Up to 28 days.
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. No participants were enrolled in Panel B and no data was collected for Panel B. One participant in Panel C receiving 24 mg MK-8189 experienced an adverse event and was down-titrated to 12 mg MK-8189 per protocol. AEs were reported separately for this participant at the 12 mg dose.
|
7.7%
1/13 • Number of events 1 • Up to 28 days.
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. No participants were enrolled in Panel B and no data was collected for Panel B. One participant in Panel C receiving 24 mg MK-8189 experienced an adverse event and was down-titrated to 12 mg MK-8189 per protocol. AEs were reported separately for this participant at the 12 mg dose.
|
7.7%
1/13 • Number of events 1 • Up to 28 days.
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. No participants were enrolled in Panel B and no data was collected for Panel B. One participant in Panel C receiving 24 mg MK-8189 experienced an adverse event and was down-titrated to 12 mg MK-8189 per protocol. AEs were reported separately for this participant at the 12 mg dose.
|
0.00%
0/1 • Up to 28 days.
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. No participants were enrolled in Panel B and no data was collected for Panel B. One participant in Panel C receiving 24 mg MK-8189 experienced an adverse event and was down-titrated to 12 mg MK-8189 per protocol. AEs were reported separately for this participant at the 12 mg dose.
|
0.00%
0/4 • Up to 28 days.
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. No participants were enrolled in Panel B and no data was collected for Panel B. One participant in Panel C receiving 24 mg MK-8189 experienced an adverse event and was down-titrated to 12 mg MK-8189 per protocol. AEs were reported separately for this participant at the 12 mg dose.
|
|
Nervous system disorders
Dystonia
|
16.7%
2/12 • Number of events 3 • Up to 28 days.
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. No participants were enrolled in Panel B and no data was collected for Panel B. One participant in Panel C receiving 24 mg MK-8189 experienced an adverse event and was down-titrated to 12 mg MK-8189 per protocol. AEs were reported separately for this participant at the 12 mg dose.
|
0.00%
0/5 • Up to 28 days.
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. No participants were enrolled in Panel B and no data was collected for Panel B. One participant in Panel C receiving 24 mg MK-8189 experienced an adverse event and was down-titrated to 12 mg MK-8189 per protocol. AEs were reported separately for this participant at the 12 mg dose.
|
0.00%
0/13 • Up to 28 days.
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. No participants were enrolled in Panel B and no data was collected for Panel B. One participant in Panel C receiving 24 mg MK-8189 experienced an adverse event and was down-titrated to 12 mg MK-8189 per protocol. AEs were reported separately for this participant at the 12 mg dose.
|
7.7%
1/13 • Number of events 1 • Up to 28 days.
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. No participants were enrolled in Panel B and no data was collected for Panel B. One participant in Panel C receiving 24 mg MK-8189 experienced an adverse event and was down-titrated to 12 mg MK-8189 per protocol. AEs were reported separately for this participant at the 12 mg dose.
|
7.7%
1/13 • Number of events 1 • Up to 28 days.
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. No participants were enrolled in Panel B and no data was collected for Panel B. One participant in Panel C receiving 24 mg MK-8189 experienced an adverse event and was down-titrated to 12 mg MK-8189 per protocol. AEs were reported separately for this participant at the 12 mg dose.
|
0.00%
0/1 • Up to 28 days.
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. No participants were enrolled in Panel B and no data was collected for Panel B. One participant in Panel C receiving 24 mg MK-8189 experienced an adverse event and was down-titrated to 12 mg MK-8189 per protocol. AEs were reported separately for this participant at the 12 mg dose.
|
0.00%
0/4 • Up to 28 days.
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. No participants were enrolled in Panel B and no data was collected for Panel B. One participant in Panel C receiving 24 mg MK-8189 experienced an adverse event and was down-titrated to 12 mg MK-8189 per protocol. AEs were reported separately for this participant at the 12 mg dose.
|
|
Nervous system disorders
Headache
|
25.0%
3/12 • Number of events 4 • Up to 28 days.
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. No participants were enrolled in Panel B and no data was collected for Panel B. One participant in Panel C receiving 24 mg MK-8189 experienced an adverse event and was down-titrated to 12 mg MK-8189 per protocol. AEs were reported separately for this participant at the 12 mg dose.
|
20.0%
1/5 • Number of events 1 • Up to 28 days.
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. No participants were enrolled in Panel B and no data was collected for Panel B. One participant in Panel C receiving 24 mg MK-8189 experienced an adverse event and was down-titrated to 12 mg MK-8189 per protocol. AEs were reported separately for this participant at the 12 mg dose.
|
0.00%
0/13 • Up to 28 days.
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. No participants were enrolled in Panel B and no data was collected for Panel B. One participant in Panel C receiving 24 mg MK-8189 experienced an adverse event and was down-titrated to 12 mg MK-8189 per protocol. AEs were reported separately for this participant at the 12 mg dose.
|
0.00%
0/13 • Up to 28 days.
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. No participants were enrolled in Panel B and no data was collected for Panel B. One participant in Panel C receiving 24 mg MK-8189 experienced an adverse event and was down-titrated to 12 mg MK-8189 per protocol. AEs were reported separately for this participant at the 12 mg dose.
|
7.7%
1/13 • Number of events 1 • Up to 28 days.
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. No participants were enrolled in Panel B and no data was collected for Panel B. One participant in Panel C receiving 24 mg MK-8189 experienced an adverse event and was down-titrated to 12 mg MK-8189 per protocol. AEs were reported separately for this participant at the 12 mg dose.
|
0.00%
0/1 • Up to 28 days.
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. No participants were enrolled in Panel B and no data was collected for Panel B. One participant in Panel C receiving 24 mg MK-8189 experienced an adverse event and was down-titrated to 12 mg MK-8189 per protocol. AEs were reported separately for this participant at the 12 mg dose.
|
25.0%
1/4 • Number of events 1 • Up to 28 days.
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. No participants were enrolled in Panel B and no data was collected for Panel B. One participant in Panel C receiving 24 mg MK-8189 experienced an adverse event and was down-titrated to 12 mg MK-8189 per protocol. AEs were reported separately for this participant at the 12 mg dose.
|
|
Nervous system disorders
Oromandibular dystonia
|
41.7%
5/12 • Number of events 5 • Up to 28 days.
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. No participants were enrolled in Panel B and no data was collected for Panel B. One participant in Panel C receiving 24 mg MK-8189 experienced an adverse event and was down-titrated to 12 mg MK-8189 per protocol. AEs were reported separately for this participant at the 12 mg dose.
|
0.00%
0/5 • Up to 28 days.
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. No participants were enrolled in Panel B and no data was collected for Panel B. One participant in Panel C receiving 24 mg MK-8189 experienced an adverse event and was down-titrated to 12 mg MK-8189 per protocol. AEs were reported separately for this participant at the 12 mg dose.
|
7.7%
1/13 • Number of events 1 • Up to 28 days.
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. No participants were enrolled in Panel B and no data was collected for Panel B. One participant in Panel C receiving 24 mg MK-8189 experienced an adverse event and was down-titrated to 12 mg MK-8189 per protocol. AEs were reported separately for this participant at the 12 mg dose.
|
7.7%
1/13 • Number of events 1 • Up to 28 days.
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. No participants were enrolled in Panel B and no data was collected for Panel B. One participant in Panel C receiving 24 mg MK-8189 experienced an adverse event and was down-titrated to 12 mg MK-8189 per protocol. AEs were reported separately for this participant at the 12 mg dose.
|
7.7%
1/13 • Number of events 1 • Up to 28 days.
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. No participants were enrolled in Panel B and no data was collected for Panel B. One participant in Panel C receiving 24 mg MK-8189 experienced an adverse event and was down-titrated to 12 mg MK-8189 per protocol. AEs were reported separately for this participant at the 12 mg dose.
|
0.00%
0/1 • Up to 28 days.
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. No participants were enrolled in Panel B and no data was collected for Panel B. One participant in Panel C receiving 24 mg MK-8189 experienced an adverse event and was down-titrated to 12 mg MK-8189 per protocol. AEs were reported separately for this participant at the 12 mg dose.
|
0.00%
0/4 • Up to 28 days.
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. No participants were enrolled in Panel B and no data was collected for Panel B. One participant in Panel C receiving 24 mg MK-8189 experienced an adverse event and was down-titrated to 12 mg MK-8189 per protocol. AEs were reported separately for this participant at the 12 mg dose.
|
|
Psychiatric disorders
Anxiety
|
41.7%
5/12 • Number of events 5 • Up to 28 days.
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. No participants were enrolled in Panel B and no data was collected for Panel B. One participant in Panel C receiving 24 mg MK-8189 experienced an adverse event and was down-titrated to 12 mg MK-8189 per protocol. AEs were reported separately for this participant at the 12 mg dose.
|
20.0%
1/5 • Number of events 1 • Up to 28 days.
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. No participants were enrolled in Panel B and no data was collected for Panel B. One participant in Panel C receiving 24 mg MK-8189 experienced an adverse event and was down-titrated to 12 mg MK-8189 per protocol. AEs were reported separately for this participant at the 12 mg dose.
|
0.00%
0/13 • Up to 28 days.
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. No participants were enrolled in Panel B and no data was collected for Panel B. One participant in Panel C receiving 24 mg MK-8189 experienced an adverse event and was down-titrated to 12 mg MK-8189 per protocol. AEs were reported separately for this participant at the 12 mg dose.
|
7.7%
1/13 • Number of events 1 • Up to 28 days.
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. No participants were enrolled in Panel B and no data was collected for Panel B. One participant in Panel C receiving 24 mg MK-8189 experienced an adverse event and was down-titrated to 12 mg MK-8189 per protocol. AEs were reported separately for this participant at the 12 mg dose.
|
15.4%
2/13 • Number of events 2 • Up to 28 days.
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. No participants were enrolled in Panel B and no data was collected for Panel B. One participant in Panel C receiving 24 mg MK-8189 experienced an adverse event and was down-titrated to 12 mg MK-8189 per protocol. AEs were reported separately for this participant at the 12 mg dose.
|
0.00%
0/1 • Up to 28 days.
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. No participants were enrolled in Panel B and no data was collected for Panel B. One participant in Panel C receiving 24 mg MK-8189 experienced an adverse event and was down-titrated to 12 mg MK-8189 per protocol. AEs were reported separately for this participant at the 12 mg dose.
|
0.00%
0/4 • Up to 28 days.
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. No participants were enrolled in Panel B and no data was collected for Panel B. One participant in Panel C receiving 24 mg MK-8189 experienced an adverse event and was down-titrated to 12 mg MK-8189 per protocol. AEs were reported separately for this participant at the 12 mg dose.
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/12 • Up to 28 days.
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. No participants were enrolled in Panel B and no data was collected for Panel B. One participant in Panel C receiving 24 mg MK-8189 experienced an adverse event and was down-titrated to 12 mg MK-8189 per protocol. AEs were reported separately for this participant at the 12 mg dose.
|
0.00%
0/5 • Up to 28 days.
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. No participants were enrolled in Panel B and no data was collected for Panel B. One participant in Panel C receiving 24 mg MK-8189 experienced an adverse event and was down-titrated to 12 mg MK-8189 per protocol. AEs were reported separately for this participant at the 12 mg dose.
|
0.00%
0/13 • Up to 28 days.
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. No participants were enrolled in Panel B and no data was collected for Panel B. One participant in Panel C receiving 24 mg MK-8189 experienced an adverse event and was down-titrated to 12 mg MK-8189 per protocol. AEs were reported separately for this participant at the 12 mg dose.
|
7.7%
1/13 • Number of events 1 • Up to 28 days.
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. No participants were enrolled in Panel B and no data was collected for Panel B. One participant in Panel C receiving 24 mg MK-8189 experienced an adverse event and was down-titrated to 12 mg MK-8189 per protocol. AEs were reported separately for this participant at the 12 mg dose.
|
15.4%
2/13 • Number of events 2 • Up to 28 days.
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. No participants were enrolled in Panel B and no data was collected for Panel B. One participant in Panel C receiving 24 mg MK-8189 experienced an adverse event and was down-titrated to 12 mg MK-8189 per protocol. AEs were reported separately for this participant at the 12 mg dose.
|
0.00%
0/1 • Up to 28 days.
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. No participants were enrolled in Panel B and no data was collected for Panel B. One participant in Panel C receiving 24 mg MK-8189 experienced an adverse event and was down-titrated to 12 mg MK-8189 per protocol. AEs were reported separately for this participant at the 12 mg dose.
|
0.00%
0/4 • Up to 28 days.
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. No participants were enrolled in Panel B and no data was collected for Panel B. One participant in Panel C receiving 24 mg MK-8189 experienced an adverse event and was down-titrated to 12 mg MK-8189 per protocol. AEs were reported separately for this participant at the 12 mg dose.
|
|
Psychiatric disorders
Suicidal ideation
|
8.3%
1/12 • Number of events 1 • Up to 28 days.
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. No participants were enrolled in Panel B and no data was collected for Panel B. One participant in Panel C receiving 24 mg MK-8189 experienced an adverse event and was down-titrated to 12 mg MK-8189 per protocol. AEs were reported separately for this participant at the 12 mg dose.
|
0.00%
0/5 • Up to 28 days.
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. No participants were enrolled in Panel B and no data was collected for Panel B. One participant in Panel C receiving 24 mg MK-8189 experienced an adverse event and was down-titrated to 12 mg MK-8189 per protocol. AEs were reported separately for this participant at the 12 mg dose.
|
0.00%
0/13 • Up to 28 days.
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. No participants were enrolled in Panel B and no data was collected for Panel B. One participant in Panel C receiving 24 mg MK-8189 experienced an adverse event and was down-titrated to 12 mg MK-8189 per protocol. AEs were reported separately for this participant at the 12 mg dose.
|
0.00%
0/13 • Up to 28 days.
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. No participants were enrolled in Panel B and no data was collected for Panel B. One participant in Panel C receiving 24 mg MK-8189 experienced an adverse event and was down-titrated to 12 mg MK-8189 per protocol. AEs were reported separately for this participant at the 12 mg dose.
|
0.00%
0/13 • Up to 28 days.
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. No participants were enrolled in Panel B and no data was collected for Panel B. One participant in Panel C receiving 24 mg MK-8189 experienced an adverse event and was down-titrated to 12 mg MK-8189 per protocol. AEs were reported separately for this participant at the 12 mg dose.
|
0.00%
0/1 • Up to 28 days.
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. No participants were enrolled in Panel B and no data was collected for Panel B. One participant in Panel C receiving 24 mg MK-8189 experienced an adverse event and was down-titrated to 12 mg MK-8189 per protocol. AEs were reported separately for this participant at the 12 mg dose.
|
0.00%
0/4 • Up to 28 days.
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. No participants were enrolled in Panel B and no data was collected for Panel B. One participant in Panel C receiving 24 mg MK-8189 experienced an adverse event and was down-titrated to 12 mg MK-8189 per protocol. AEs were reported separately for this participant at the 12 mg dose.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
8.3%
1/12 • Number of events 1 • Up to 28 days.
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. No participants were enrolled in Panel B and no data was collected for Panel B. One participant in Panel C receiving 24 mg MK-8189 experienced an adverse event and was down-titrated to 12 mg MK-8189 per protocol. AEs were reported separately for this participant at the 12 mg dose.
|
0.00%
0/5 • Up to 28 days.
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. No participants were enrolled in Panel B and no data was collected for Panel B. One participant in Panel C receiving 24 mg MK-8189 experienced an adverse event and was down-titrated to 12 mg MK-8189 per protocol. AEs were reported separately for this participant at the 12 mg dose.
|
0.00%
0/13 • Up to 28 days.
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. No participants were enrolled in Panel B and no data was collected for Panel B. One participant in Panel C receiving 24 mg MK-8189 experienced an adverse event and was down-titrated to 12 mg MK-8189 per protocol. AEs were reported separately for this participant at the 12 mg dose.
|
0.00%
0/13 • Up to 28 days.
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. No participants were enrolled in Panel B and no data was collected for Panel B. One participant in Panel C receiving 24 mg MK-8189 experienced an adverse event and was down-titrated to 12 mg MK-8189 per protocol. AEs were reported separately for this participant at the 12 mg dose.
|
0.00%
0/13 • Up to 28 days.
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. No participants were enrolled in Panel B and no data was collected for Panel B. One participant in Panel C receiving 24 mg MK-8189 experienced an adverse event and was down-titrated to 12 mg MK-8189 per protocol. AEs were reported separately for this participant at the 12 mg dose.
|
0.00%
0/1 • Up to 28 days.
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. No participants were enrolled in Panel B and no data was collected for Panel B. One participant in Panel C receiving 24 mg MK-8189 experienced an adverse event and was down-titrated to 12 mg MK-8189 per protocol. AEs were reported separately for this participant at the 12 mg dose.
|
0.00%
0/4 • Up to 28 days.
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. No participants were enrolled in Panel B and no data was collected for Panel B. One participant in Panel C receiving 24 mg MK-8189 experienced an adverse event and was down-titrated to 12 mg MK-8189 per protocol. AEs were reported separately for this participant at the 12 mg dose.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinitis allergic
|
0.00%
0/12 • Up to 28 days.
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. No participants were enrolled in Panel B and no data was collected for Panel B. One participant in Panel C receiving 24 mg MK-8189 experienced an adverse event and was down-titrated to 12 mg MK-8189 per protocol. AEs were reported separately for this participant at the 12 mg dose.
|
20.0%
1/5 • Number of events 1 • Up to 28 days.
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. No participants were enrolled in Panel B and no data was collected for Panel B. One participant in Panel C receiving 24 mg MK-8189 experienced an adverse event and was down-titrated to 12 mg MK-8189 per protocol. AEs were reported separately for this participant at the 12 mg dose.
|
0.00%
0/13 • Up to 28 days.
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. No participants were enrolled in Panel B and no data was collected for Panel B. One participant in Panel C receiving 24 mg MK-8189 experienced an adverse event and was down-titrated to 12 mg MK-8189 per protocol. AEs were reported separately for this participant at the 12 mg dose.
|
0.00%
0/13 • Up to 28 days.
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. No participants were enrolled in Panel B and no data was collected for Panel B. One participant in Panel C receiving 24 mg MK-8189 experienced an adverse event and was down-titrated to 12 mg MK-8189 per protocol. AEs were reported separately for this participant at the 12 mg dose.
|
0.00%
0/13 • Up to 28 days.
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. No participants were enrolled in Panel B and no data was collected for Panel B. One participant in Panel C receiving 24 mg MK-8189 experienced an adverse event and was down-titrated to 12 mg MK-8189 per protocol. AEs were reported separately for this participant at the 12 mg dose.
|
0.00%
0/1 • Up to 28 days.
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. No participants were enrolled in Panel B and no data was collected for Panel B. One participant in Panel C receiving 24 mg MK-8189 experienced an adverse event and was down-titrated to 12 mg MK-8189 per protocol. AEs were reported separately for this participant at the 12 mg dose.
|
0.00%
0/4 • Up to 28 days.
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. No participants were enrolled in Panel B and no data was collected for Panel B. One participant in Panel C receiving 24 mg MK-8189 experienced an adverse event and was down-titrated to 12 mg MK-8189 per protocol. AEs were reported separately for this participant at the 12 mg dose.
|
|
Skin and subcutaneous tissue disorders
Dermatitis contact
|
8.3%
1/12 • Number of events 1 • Up to 28 days.
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. No participants were enrolled in Panel B and no data was collected for Panel B. One participant in Panel C receiving 24 mg MK-8189 experienced an adverse event and was down-titrated to 12 mg MK-8189 per protocol. AEs were reported separately for this participant at the 12 mg dose.
|
0.00%
0/5 • Up to 28 days.
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. No participants were enrolled in Panel B and no data was collected for Panel B. One participant in Panel C receiving 24 mg MK-8189 experienced an adverse event and was down-titrated to 12 mg MK-8189 per protocol. AEs were reported separately for this participant at the 12 mg dose.
|
0.00%
0/13 • Up to 28 days.
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. No participants were enrolled in Panel B and no data was collected for Panel B. One participant in Panel C receiving 24 mg MK-8189 experienced an adverse event and was down-titrated to 12 mg MK-8189 per protocol. AEs were reported separately for this participant at the 12 mg dose.
|
0.00%
0/13 • Up to 28 days.
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. No participants were enrolled in Panel B and no data was collected for Panel B. One participant in Panel C receiving 24 mg MK-8189 experienced an adverse event and was down-titrated to 12 mg MK-8189 per protocol. AEs were reported separately for this participant at the 12 mg dose.
|
0.00%
0/13 • Up to 28 days.
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. No participants were enrolled in Panel B and no data was collected for Panel B. One participant in Panel C receiving 24 mg MK-8189 experienced an adverse event and was down-titrated to 12 mg MK-8189 per protocol. AEs were reported separately for this participant at the 12 mg dose.
|
0.00%
0/1 • Up to 28 days.
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. No participants were enrolled in Panel B and no data was collected for Panel B. One participant in Panel C receiving 24 mg MK-8189 experienced an adverse event and was down-titrated to 12 mg MK-8189 per protocol. AEs were reported separately for this participant at the 12 mg dose.
|
0.00%
0/4 • Up to 28 days.
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. No participants were enrolled in Panel B and no data was collected for Panel B. One participant in Panel C receiving 24 mg MK-8189 experienced an adverse event and was down-titrated to 12 mg MK-8189 per protocol. AEs were reported separately for this participant at the 12 mg dose.
|
|
Skin and subcutaneous tissue disorders
Ecchymosis
|
0.00%
0/12 • Up to 28 days.
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. No participants were enrolled in Panel B and no data was collected for Panel B. One participant in Panel C receiving 24 mg MK-8189 experienced an adverse event and was down-titrated to 12 mg MK-8189 per protocol. AEs were reported separately for this participant at the 12 mg dose.
|
20.0%
1/5 • Number of events 1 • Up to 28 days.
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. No participants were enrolled in Panel B and no data was collected for Panel B. One participant in Panel C receiving 24 mg MK-8189 experienced an adverse event and was down-titrated to 12 mg MK-8189 per protocol. AEs were reported separately for this participant at the 12 mg dose.
|
0.00%
0/13 • Up to 28 days.
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. No participants were enrolled in Panel B and no data was collected for Panel B. One participant in Panel C receiving 24 mg MK-8189 experienced an adverse event and was down-titrated to 12 mg MK-8189 per protocol. AEs were reported separately for this participant at the 12 mg dose.
|
0.00%
0/13 • Up to 28 days.
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. No participants were enrolled in Panel B and no data was collected for Panel B. One participant in Panel C receiving 24 mg MK-8189 experienced an adverse event and was down-titrated to 12 mg MK-8189 per protocol. AEs were reported separately for this participant at the 12 mg dose.
|
0.00%
0/13 • Up to 28 days.
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. No participants were enrolled in Panel B and no data was collected for Panel B. One participant in Panel C receiving 24 mg MK-8189 experienced an adverse event and was down-titrated to 12 mg MK-8189 per protocol. AEs were reported separately for this participant at the 12 mg dose.
|
0.00%
0/1 • Up to 28 days.
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. No participants were enrolled in Panel B and no data was collected for Panel B. One participant in Panel C receiving 24 mg MK-8189 experienced an adverse event and was down-titrated to 12 mg MK-8189 per protocol. AEs were reported separately for this participant at the 12 mg dose.
|
0.00%
0/4 • Up to 28 days.
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. No participants were enrolled in Panel B and no data was collected for Panel B. One participant in Panel C receiving 24 mg MK-8189 experienced an adverse event and was down-titrated to 12 mg MK-8189 per protocol. AEs were reported separately for this participant at the 12 mg dose.
|
|
Skin and subcutaneous tissue disorders
Eczema
|
0.00%
0/12 • Up to 28 days.
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. No participants were enrolled in Panel B and no data was collected for Panel B. One participant in Panel C receiving 24 mg MK-8189 experienced an adverse event and was down-titrated to 12 mg MK-8189 per protocol. AEs were reported separately for this participant at the 12 mg dose.
|
0.00%
0/5 • Up to 28 days.
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. No participants were enrolled in Panel B and no data was collected for Panel B. One participant in Panel C receiving 24 mg MK-8189 experienced an adverse event and was down-titrated to 12 mg MK-8189 per protocol. AEs were reported separately for this participant at the 12 mg dose.
|
0.00%
0/13 • Up to 28 days.
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. No participants were enrolled in Panel B and no data was collected for Panel B. One participant in Panel C receiving 24 mg MK-8189 experienced an adverse event and was down-titrated to 12 mg MK-8189 per protocol. AEs were reported separately for this participant at the 12 mg dose.
|
0.00%
0/13 • Up to 28 days.
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. No participants were enrolled in Panel B and no data was collected for Panel B. One participant in Panel C receiving 24 mg MK-8189 experienced an adverse event and was down-titrated to 12 mg MK-8189 per protocol. AEs were reported separately for this participant at the 12 mg dose.
|
7.7%
1/13 • Number of events 1 • Up to 28 days.
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. No participants were enrolled in Panel B and no data was collected for Panel B. One participant in Panel C receiving 24 mg MK-8189 experienced an adverse event and was down-titrated to 12 mg MK-8189 per protocol. AEs were reported separately for this participant at the 12 mg dose.
|
0.00%
0/1 • Up to 28 days.
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. No participants were enrolled in Panel B and no data was collected for Panel B. One participant in Panel C receiving 24 mg MK-8189 experienced an adverse event and was down-titrated to 12 mg MK-8189 per protocol. AEs were reported separately for this participant at the 12 mg dose.
|
0.00%
0/4 • Up to 28 days.
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. No participants were enrolled in Panel B and no data was collected for Panel B. One participant in Panel C receiving 24 mg MK-8189 experienced an adverse event and was down-titrated to 12 mg MK-8189 per protocol. AEs were reported separately for this participant at the 12 mg dose.
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
16.7%
2/12 • Number of events 2 • Up to 28 days.
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. No participants were enrolled in Panel B and no data was collected for Panel B. One participant in Panel C receiving 24 mg MK-8189 experienced an adverse event and was down-titrated to 12 mg MK-8189 per protocol. AEs were reported separately for this participant at the 12 mg dose.
|
0.00%
0/5 • Up to 28 days.
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. No participants were enrolled in Panel B and no data was collected for Panel B. One participant in Panel C receiving 24 mg MK-8189 experienced an adverse event and was down-titrated to 12 mg MK-8189 per protocol. AEs were reported separately for this participant at the 12 mg dose.
|
0.00%
0/13 • Up to 28 days.
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. No participants were enrolled in Panel B and no data was collected for Panel B. One participant in Panel C receiving 24 mg MK-8189 experienced an adverse event and was down-titrated to 12 mg MK-8189 per protocol. AEs were reported separately for this participant at the 12 mg dose.
|
0.00%
0/13 • Up to 28 days.
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. No participants were enrolled in Panel B and no data was collected for Panel B. One participant in Panel C receiving 24 mg MK-8189 experienced an adverse event and was down-titrated to 12 mg MK-8189 per protocol. AEs were reported separately for this participant at the 12 mg dose.
|
0.00%
0/13 • Up to 28 days.
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. No participants were enrolled in Panel B and no data was collected for Panel B. One participant in Panel C receiving 24 mg MK-8189 experienced an adverse event and was down-titrated to 12 mg MK-8189 per protocol. AEs were reported separately for this participant at the 12 mg dose.
|
0.00%
0/1 • Up to 28 days.
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. No participants were enrolled in Panel B and no data was collected for Panel B. One participant in Panel C receiving 24 mg MK-8189 experienced an adverse event and was down-titrated to 12 mg MK-8189 per protocol. AEs were reported separately for this participant at the 12 mg dose.
|
25.0%
1/4 • Number of events 1 • Up to 28 days.
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. No participants were enrolled in Panel B and no data was collected for Panel B. One participant in Panel C receiving 24 mg MK-8189 experienced an adverse event and was down-titrated to 12 mg MK-8189 per protocol. AEs were reported separately for this participant at the 12 mg dose.
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/12 • Up to 28 days.
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. No participants were enrolled in Panel B and no data was collected for Panel B. One participant in Panel C receiving 24 mg MK-8189 experienced an adverse event and was down-titrated to 12 mg MK-8189 per protocol. AEs were reported separately for this participant at the 12 mg dose.
|
20.0%
1/5 • Number of events 1 • Up to 28 days.
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. No participants were enrolled in Panel B and no data was collected for Panel B. One participant in Panel C receiving 24 mg MK-8189 experienced an adverse event and was down-titrated to 12 mg MK-8189 per protocol. AEs were reported separately for this participant at the 12 mg dose.
|
0.00%
0/13 • Up to 28 days.
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. No participants were enrolled in Panel B and no data was collected for Panel B. One participant in Panel C receiving 24 mg MK-8189 experienced an adverse event and was down-titrated to 12 mg MK-8189 per protocol. AEs were reported separately for this participant at the 12 mg dose.
|
0.00%
0/13 • Up to 28 days.
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. No participants were enrolled in Panel B and no data was collected for Panel B. One participant in Panel C receiving 24 mg MK-8189 experienced an adverse event and was down-titrated to 12 mg MK-8189 per protocol. AEs were reported separately for this participant at the 12 mg dose.
|
0.00%
0/13 • Up to 28 days.
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. No participants were enrolled in Panel B and no data was collected for Panel B. One participant in Panel C receiving 24 mg MK-8189 experienced an adverse event and was down-titrated to 12 mg MK-8189 per protocol. AEs were reported separately for this participant at the 12 mg dose.
|
0.00%
0/1 • Up to 28 days.
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. No participants were enrolled in Panel B and no data was collected for Panel B. One participant in Panel C receiving 24 mg MK-8189 experienced an adverse event and was down-titrated to 12 mg MK-8189 per protocol. AEs were reported separately for this participant at the 12 mg dose.
|
0.00%
0/4 • Up to 28 days.
All-Cause Mortality is reported for all randomized participants. Serious Adverse Events and Other Adverse Events are reported for all participants who received treatment. No participants were enrolled in Panel B and no data was collected for Panel B. One participant in Panel C receiving 24 mg MK-8189 experienced an adverse event and was down-titrated to 12 mg MK-8189 per protocol. AEs were reported separately for this participant at the 12 mg dose.
|
Additional Information
Senior Vice President, Global Clinical Development
Merck Sharp & Dohme LLC
Phone: 1-800-672-6372
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee If publication activity is not directed by the Sponsor, the investigator agrees to submit all manuscripts or abstracts to the Sponsor before submission. Authorship will be determined by mutual agreement and in line with International Committee of Medical Journal Editors authorship requirements.
- Publication restrictions are in place
Restriction type: OTHER